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SBE- The Federal Regulations Exam Graded A+
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SBE- The Federal Regulations Exam Graded A+
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SBE- The Federal Regulations ExamGraded A+
A criterion for waiving informed consent is that, when appropriate, subjects are provided
additional pertinent information after the study. In which of the following studies would it
NOT be appropriate to provide subjects with information about missing elements of
consent: - ANSWER-A study in which subjects were assigned to study activities based
on an undesirable or unflattering physical characteristic as assessed by members of the
research team
A financial conflict of interest could involve - ANSWER-Receiving stock in a company
funding your research.
A general requirement for informed consent is that no informed consent may include
any exculpatory language. Exculpatory language is that which waives or appears to
waive any of the subject's legal rights or releases or appears to release those
conducting the research from liability for negligence. Which of the following statements
in a consent form is an example of exculpatory language? - ANSWER-Taking part in the
research is voluntary, but if you choose to take part, you waive the right to legal redress
for any research-related injuries.
A graduate student wants to examine the effect of print media versus televised media
on individuals' position on several social issues. The superintendent of a local work
release facility, a family friend, will allow the graduate student access to the prison
population to help her quickly accrue subjects. The student's IRB should: - ANSWER-
Not approve this project because the prisoners are merely a population of convenience
for the student.
A HIPAA authorization has which of the following characteristics: - ANSWER-Uses
"plain language" that the data subject can understand, similar to the requirement for an
informed consent document.
A master's degree candidate needs to conduct a research project for her master's
thesis. She is interested in the types of junk food available to the public. She plans on
going to the local convenience stores and asking the owners what types of junk food the
store normally stock and which are the biggest sellers. Identifiers will not be collected.
This study would fall under which of the following? - ANSWER-not human subjects
A medical record is an example of - ANSWER-private information
A professor at Big State University is writing a biography about Bill Gates and
conducting oral histories with all of Bill Gates' friends, family members and business
acquaintances. The researcher submits the research proposal to the institution's IRB.
, What action can he expect by the IRB? - ANSWER-The IRB will not review this study
because it is not research as defined by the federal regulations.
A researcher asks an IRB to waive the requirement for parental permission for a study
conducted in schools because the nature of the research requires participation of all the
children present in classrooms on the day the research will take place. Assuming that
the basic research design could be approved by the IRB and the school, which of the
following requirements must be met before an IRB could waive parental permission? -
ANSWER-research must pose no more than minimal risk
A researcher is studying women recently admitted to a state prison. All potential
subjects must have children under the age of five. Research subjects will be given a
basket of toys to use at their children's first visit that the children can then take home. In
assessing this proposal, the IRB needs to determine that the toys are: - ANSWER-not
an excessive incentive
A researcher leaves a research file in her car while she attends a concert and her car is
stolen. The file contains charts of aggregated numerical data from a research study with
human subjects, but no other documents. The consent form said that no identifying
information would be retained, and the researcher adhered to that component. Which of
the following statements best characterizes what occurred? - ANSWER-There was
neither a violation of privacy nor a breach of confidentiality.
A situation in which financial or other personal considerations have the potential to
compromise or bias professional judgment and objectivity is an example of: - ANSWER-
conflict of interest
A student is conducting a research project that involves using a survey. The survey
asks participants about their highest level of education, political affiliation, and views on
various social issues. No identifiable information will be collected. This study would be
categorized as which type of review? - ANSWER-exempt review
A student working on his dissertation plans on interviewing 15 principals in neighboring
high schools. The student plans to collect data about the personal experiences the
principals have had with disruptive students, what types of disciplinary actions were
taken (including decisions they may have personally made), and their feelings or
thoughts as to whether those actions were appropriate. Identifiers will be collected. This
study would be categorized as which type of review? - ANSWER-full board review
A study that involves interviews of adults is eligible for expedited review. The researcher
wants to add an adolescent population (aged 12 to 17) to the study and has designed a
parental permission and assent process. No additional changes are planned. Which of
the following statements about review of the revised protocol is accurate? - ANSWER-
Unless the nature of the questions would raise the level of risk to more than minimal for
adolescents, the research would still qualify for expedited review.
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